LDSO/RDSO Flyer - May-June 2021 - 19

Manufactured Under Aseptic Conditions
Unlike Compound Pharmacies

DYCLOPRO

™

TOPICAL ANESTHETIC
(Dyclonine Hydrochloride Topical Solution 0.5%)
Dyclonine, an old favorite, has returned to the United States
market. DycloPro is a topical rinse indicated for use in root
planing and scaling, for blocking the gag reflex and prior to
the injections of local anesthetics.

FEATURES

BENEFITS

30g jar

Multiple doses in each jar

2-10 minute onset within 30 minute duration

For use in scaling (prophylaxis)

Available in the Apple
Store & Google Play

PRODUCT
Topical Anesthetic

ITEM #
228-6038

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BRIEF SUMMARY OF PRESCRIBING INFORMATION
INDICATIONS: DycloPro (Dyclonine HCl Topical Solution) is a
topical anesthetic indicated for anesthetizing accessible mucous
membranes prior to various endoscopic procedures and may also
be used to block the gag reflex and to relieve the pain of oral ulcers
or stomatitis.
ALTERNATIVE INDICATIONS: DycloPro is useful to suppress
the gag reflex in the positioning of x-ray films, making prosthetic
impressions, and doing surgical procedures in the molar areas. It
is also useful as a preinjection mucous membrane anesthetic or
applied to the gums prior to scaling (prophylaxis). The anesthetic
can be applied as a mouthwash or gargle and the excess spit out.
CONTRAINDICATIONS: Do not inject into tissue or use in the eyes.
DycloPro is contraindicated in patients known to be allergic to the
local anesthetic or to other components of Dyclonine HCl Topical
Solution. DycloPro should not be injected into tissue or used in
the eyes because of highly irritant properties. DycloPro should be
used with extreme caution in the presence of sepsis or severely
traumatized mucosa in the area of application since under such
conditions there is the potential for rapid systemic absorption.
PRECAUTIONS: The safety and effectiveness of DycloPro depends
on proper dosage, correct technique, adequate precautions, and
readiness for emergencies. The lowest dosage that results in
effective anesthesia should be used to avoid high plasma levels

and serious adverse effects. Repeated doses of DycloPro may
cause significant increases in blood levels with each repeated
dose because of slow accumulation of the drug or its metabolites.
Tolerance to elevated blood levels varies with the status of the
patient. Debilitated, elderly patients, acutely ill patients and children
should be given reduced doses commensurate with their age,
weight and physical condition. DycloPro should also be used with
caution in patients with severe shock or heart block or with known
drug sensitivities.
INFORMATION FOR PATIENTS: When topical anesthetics are
used in the mouth or throat, the patient should be aware that the
production of topical anesthesia may impair swallowing and thus
enhance the danger of aspiration. For this reason, food should
not be ingested for 60 minutes following use of local anesthetic
preparations in the mouth or throat area. This is particularly
important in children because of their frequency of eating.
Numbness of the tongue or buccal mucosa may increase the danger
of biting trauma. When Dyclonine HCl Topical Solution is used to
relieve the pain of oral ulcers or stomatitis which interferes with
eating, patients should be warned about the risk of biting trauma
before they accept this treatment; caution should be exercised in
selecting food and eating. Following other uses in the mouth and
throat area, food and/or chewing gum should not be used while the
area is anesthetized.

PREGNANCY/PEDIATRIC USE: Animal reproduction studies have
not been conducted with dyclonine. It is also not known whether
dyclonine can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Safety and effectiveness
in children under the age of 12 have not been established.
ADVERSE REACTIONS: Adverse experiences following the
administration of DycloPro are similar in nature to those observed
with other local anesthetic agents. These adverse experiences are,
in general, dose-related and may result from high plasma levels
caused by excessive dosage or rapid absorption, or may result from
a hypersensitivity, idiosyncrasy or diminished tolerance on the part
of the patient. Serious adverse experiences are generally systemic
in nature.
HOW SUPPLIED:
Sterile, in one fluid ounce bottles.
Dyclonine HCl Topical Solution 0.5%
(NDC-0362-3971-05)
Keep tightly closed. Store at controlled room temperature 20º-25ºC
(68º-77ºF). Avoid excessive heat (temperatures above 40ºC [104ºF]).
Subject to damage by freezing.
For Complete prescribing information visit
www.septodonusa.com/dyclopro
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

septodontusa.com ∙ From the manufacturers of Septocaine ∙ anesthetics ∙ materials ∙ endodontics

21GP2511

henryscheindental.com

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LDSO/RDSO Flyer - May-June 2021

Table of Contents for the Digital Edition of LDSO/RDSO Flyer - May-June 2021